(22 days)
The intended use of the Modified Device is to provide stability and directional control during transcatheter ablation of endocardial tissue.
PREFACE Braided Guiding Sheath - The intended use of the percutaneous Braided Guiding Sheath is for the introduction of intravascular electrophysiology catheters into any cardiac chamber.
PERRY Exchange Dilator - The intended use of the PERRY Exchange Dilator is for the transseptal exchange of Cordis Webster PREFACE Braided Guiding Sheaths which are used for the introduction of intravascular electrophysiology catheters. The exchange dilator permits exchange of the guiding sheaths while maintaining transseptal left heart access and control of sheath location.
The components of the Predicate Device (K970264) consists of 1) a Guiding Sheath with posterior, anterior or multipurpose shaped distal tip section, 2) a conventional sheath vessel dilator (vessel dilator), 3) a dual-tapered long vessel dilator (exchange dilator), 4) a .032", 260cm guidewire, and 5) a guidewire funnel. The components of the Predicate Device are packaged in four configurations: 1) Guiding Sheath w/ posterior curve and vessel dilator, 2) Guiding Sheath w/ anterior curve and vessel dilator, 3) Guiding Sheath w/ multipurpose curve, vessel dilator, exchange dilator, .032", 260cm guidewire and guidewire funnel, and 4) Posterior, Anterior and Multipurpose Guiding Sheaths, vessel dilator, exchange dilator, .032", 260cm guidewire and guidewire funnel.
The packaging configuration of the Predicate Device has been modified to offer the Guiding Sheath and Exchange System in two separate packages. The Guiding Sheath (PREFACE Braided Guiding Sheath) with posterior, anterior or multipurpose shaped distal tip sections is packaged with a vessel dilator and a short .032", 150cm guidewire. The Exchange System includes the exchange dilator (PERRY Exchange Dilator), .032", 260cm guidewire, and guidewire funnel. The distal end of the vessel dilator and both ends of the PERRY Exchange Dilator were modified by adding radiopaque tips with tungsten to improve visibility under fluoroscopy. The function and intended use of the Modified Device as compared to the Predicate Device are identical, as are all component materials with the exception of the tungsten dilator material. The addition of the tungsten material does not affect safety or effectiveness as demonstrated in the Verification Test Data provided in Appendix I.
The PREFACE Braided Guiding Sheaths are intended to provide stability and directional control during catheter ablation. The PREFACE Braided Guiding Sheath is packaged with a vessel dilator with a radiopaque distal tip, and a .032", 150cm guidewire. The PERRY Exchange Dilator will be utilized by the physician to exchange the existing PREFACE Braided Guiding Sheath for an alternate PREFACE Braided Guiding Sheath without losing the established intracardiac position. The PERRY Exchange Dilator with radiopaque ends is packaged with a .032", 260cm guidewire and guidewire funnel.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
The document (K982740) describes a Special 510(k) for a "Device Modification Cordis Webster Braided Guiding Sheath Exchange System." This is a modification of an existing device (Predicate Device K970264). The core of this submission is to demonstrate that the modified device is substantially equivalent to the predicate device, particularly because of changes made to the dilators (adding radiopaque tips with tungsten for improved visibility).
Key Finding: This submission does not detail a study with specific acceptance criteria related to a diagnostic or AI-based performance. Instead, it focuses on verification testing to demonstrate that the modification (the addition of tungsten to the dilators) does not adversely affect the device's safety or effectiveness compared to the predicate device.
Therefore, many of the requested categories (like performance metrics, sample size for test sets/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and AI-specific ground truth) are not applicable to this type of device modification submission.
Acceptance Criteria and Study Details (Based on Provided Text)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Report) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Properties | |
| Stiffness of PERRY Exchange Dilator with radiopaque tip is comparable to predicate/standard dilator. | Verification testing was conducted to compare the stiffness of the PERRY Exchange Dilator with radiopaque tip and the dilator (of the PREFACE Braided Guiding Sheath) with the standard 8F AVANTI Sheath (K970392). The data supports substantial equivalence. |
| Insertion force of PERRY Exchange Dilator with radiopaque tip is comparable to predicate/standard dilator. | Verification testing was conducted to compare the insertion force of the PERRY Exchange Dilator with radiopaque tip and the dilator (of the PREFACE Braided Guiding Sheath) with the standard 8F AVANTI Sheath (K970392). The data supports substantial equivalence. |
| Material Biocompatibility/Safety | |
| Addition of tungsten material does not affect safety or effectiveness. | "The addition of the tungsten material does not affect safety or effectiveness as demonstrated in the Verification Test Data provided in Appendix I." (Appendix I is not provided in the given text, but the statement confirms this was addressed). |
| Function and Intended Use | |
| Modified Device maintains identical function and intended use as the Predicate Device. | "The function and intended use of the Modified Device as compared to the Predicate Device are identical, as are all component materials with the exception of the tungsten dilator material." The verification tests are intended to confirm this. |
| Improved Visibility | |
| Radiopaque tips (with tungsten) improve visibility under fluoroscopy. | "The distal end of the vessel dilator and both ends of the PERRY Exchange Dilator were modified by adding radiopaque tips with tungsten to improve visibility under fluoroscopy." (This is a design intent and likely confirmed by visual inspection/testing, though specific metrics aren't detailed in this summary). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided summary. The submission refers to "Verification Test Data provided in Appendix I," which is not included. These types of tests typically involve a limited number of physical samples (e.g., a few units of each size/component for mechanical testing).
- Data Provenance: Not specified, but generally, such verification testing is conducted in a controlled lab environment by the device manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is not a diagnostic device or an AI-algorithm requiring expert ground truth in that sense. The "ground truth" for mechanical properties would be derived from standard engineering measurement techniques and comparison to established benchmarks (e.g., the predicate device or a standard sheath).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not a diagnostic device, and no AI component is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI-enabled device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The ground truth for the mechanical properties (stiffness, insertion force) would likely be quantitative physical measurements obtained through standard engineering testing methods. The "ground truth" for safety and effectiveness relative to the modification is the comparison against the predicate device's established performance and relevant material standards.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not a machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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AUG 28 1998
Special 510(k): Device Modificatio Cordis Webster Braided Guiding Sheath Exchange System
Appendix A: 510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined under theFederal Food, Drug and Cosmetic Act, respecting safety and effectiveness issummarized below. |
|---|---|
| For the convenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule "...510(k) Summaries and 510(k)Statements..." (21 CFR §807) and can be used to provide a substantialequivalence summary to anyone requesting it from the Agency. | |
| Devicedescription | The components of the Predicate Device (K970264) consists of 1) a GuidingSheath with posterior, anterior or multipurpose shaped distal tip section, 2) aconventional sheath vessel dilator ( vessel dilator ), 3) a dual-tapered longvessel dilator ( exchange dilator ), 4) a .032", 260cm guidewire, and 5) aguidewire funnel. The components of the Predicate Device are packaged infour configurations: 1) Guiding Sheath w/ posterior curve and vessel dilator,2) Guiding Sheath w/ anterior curve and vessel dilator, 3) Guiding Sheath w/multipurpose curve, vessel dilator, exchange dilator, .032", 260cm guidewireand guidewire funnel, and 4) Posterior, Anterior and Multipurpose GuidingSheaths, vessel dilator, exchange dilator, .032", 260cm guidewire andguidewire funnel. |
| The packaging configuration of the Predicate Device has been modified tooffer the Guiding Sheath and Exchange System in two separate packages.The Guiding Sheath ( PREFACE Braided Guiding Sheath ) with posterior,anterior or multipurpose shaped distal tip sections is packaged with a vesseldilator and a short .032", 150cm guidewire. The Exchange System includesthe exchange dilator ( PERRY Exchange Dilator ), .032", 260cm guidewire,and guidewire funnel. The distal end of the vessel dilator and both ends of thePERRY Exchange Dilator were modified by adding radiopaque tips withtungsten to improve visibility under fluoroscopy. The function and intendeduse of the Modified Device as compared to the Predicate Device are identical,as are all component materials with the exception of the tungsten dilatormaterial. The addition of the tungsten material does not affect safety oreffectiveness as demonstrated in the Verification Test Data provided inAppendix I. | |
| DeviceDescription -Continued | The PREFACE Braided Guiding Sheaths are intended to provide stability anddirectional control during catheter ablation. The PREFACE Braided GuidingSheath is packaged with a vessel dilator with a radiopaque distal tip, and a.032", 150cm guidewire. The PERRY Exchange Dilator will be utilized bythe physician to exchange the existing PREFACE Braided Guiding Sheath foran alternate PREFACE Braided Guiding Sheath without losing the establishedintracardiac position. The PERRY Exchange Dilator with radiopaque ends ispackaged with a .032", 260cm guidewire and guidewire funnel. |
| Intended use | The intended use of the Modified Device is to provide stability and directionalcontrol during transcatheter ablation of endocardial tissue. |
| Indicationsstatement | PREFACE Braided Guiding Sheath - The intended use of the percutaneousBraided Guiding Sheath is for the introduction of intravascularelectrophysiology catheters into any cardiac chamber. |
| PERRY Exchange Dilator - The intended use of the PERRY ExchangeDilator is for the transseptal exchange of Cordis Webster PREFACE Braided Guiding Sheaths which are used for the introduction of intravascularelectrophysiology catheters. The exchange dilator permits exchange of theguiding sheaths while maintaining transseptal left heart access and control ofsheath location. | |
| Technologicalcharacteristics | The technological characteristics of the Modified Device are the same as thePredicate Device. |
| Continued on next page | |
| Performancedata | Verification testing of the Modified Device was conducted to compare thestiffness and the insertion force of the PERRY Exchange Dilator withradiopaque tip and the dilator (of the PREFACE Braided Guiding Sheath)with the standard 8F AVANTI Sheath (K970392). |
| Conclusion | Based on the 510(k) summaries and the 510(k) statements (21 CFR §807) andthe information provided herein, we conclude that the Modified Device issubstantially equivalent to the Predicate Device under the Federal Food, Drugand Cosmetic Act. |
| Contact | Mary AdamsRegulatory Affairs ManagerCordis Webster, Inc.4750 Littlejohn StreetBaldwin Park, CA 91706 |
| Date | August 5, 1998 |
Continued on next page
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Appendix A: 510(k) Summary of Safety and Effectiveness, Continued
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Appendix A: 510(k) Summary of Safety and Effectiveness,
Continued
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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 28 1998
Ms. Mary Adams Requlatory Affairs Manager Cordis Webster, Inc. 4750 Littlejohn Street Baldwin Park, CA 91706
Re: K982740 Cordis Webster PREFACE Braided Guiding Sheath and PERRY Exchange Dilator Regulatory Class: II (two) Product Code: 74 DYB Dated: Auqust 5, 1998 Received: Auqust 6, 1998
Dear Ms. Adams:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturinq Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, ² Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix B: Indications for Use Statement
Statement
Indications for Use Statement:
510(k) Number: K_982740
Device Name: PREFACE Braided Guiding Sheath and PERRY Exchange Dilator
Indications for Use: The PREFACE Braided Guiding Sheath is intended for the introduction of intravascular electrophysiology catheters into any cardiac chamber.
Indications for Use: The intended use of the PERRY Exchange Dilator is for the transseptal exchange of Cordis Webster PREFACE Braided Guiding Sheaths which are used for the introduction of intravascular electrophysiology catheters. The exchange dilator permits exchange of the guiding sheaths while maintaining transseptal left heart access and control of sheath location.
Qarly Tillh
Prescription Use
(Per 21 CFR 801.109)
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).